NCT07145073招募中不适用
Repetitive Transcranial Alternating Current Stimulation(rtACS) for the Treatment of Optic Neuropathies
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Change in visual field mean deviation (MD) from baseline to post-treatment
研究概览
简要总结
The goal of this study is to see whether repeated transcranial alternating current stimulation can activate impaired retinal ganglion cells and improve both structural and functional outcomes in patients with glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be at least
- •Clinical diagnosis of glaucoma, with Humphrey Visual Field 24-2 mean deviation (MD) between -22 dB and -5 dB, and Visual Field Index (VFI) between 10% and 90%. The visual field test at screening must meet the following reliability indices:
- •Fixation losses (FL) ≤ 33%
- •False-negative rate (FNR) ≤ 20%
- •False-positive rate (FPR) ≤ 20% At initial screening, the difference in MD between two consecutive visual field tests must be less than 2 dB.
- •Best-corrected visual acuity (BCVA) ≥ 0.2 in the worse eye selected for stimulation treatment.
- •If a participant has two eyes meeting study criteria, one eye will be randomly selected by computer for study participation.
- •In the opinion of the investigator the participant's eye pressure must be clinically stable.
- •Participant must has the ability to comply with the requirements of the study and complete the schedule of events.
- •Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.
- •Optical coherence tomography (OCT) imaging shows measurable changes in either peripapillary retinal nerve fiber layer (RNFL) thickness or macular ganglion cell-inner plexiform layer thickness.
排除标准
- •History of ocular herpes.
- •Pathological nystagmus.
- •Retinal disease sufficient to affect vision.
- •Corneal opacity affecting vision.
- •Cataract affecting vision.
- •Uveitis or other intraocular inflammatory disease.
- •Implanted electronic devices such as a pacemaker.
- •Rheumatologic or autoimmune disease.
- •Brain tumor or intracranial magnetic metallic implants.
- •History of epilepsy.
- •Periocular skin lesions.
- •Anxiety with Geriatric Anxiety Scale score >
- •History of claustrophobia.
- •Participation in another clinical trial within the past 3 months involving medication or training that could affect the eyes.
- •Physical or mental conditions that may increase the risk of participation or interfere with study assessments (e.g., dementia).
- •Previous ocular electrical stimulation treatment or visual training study within the past 12 months.
- •Uncontrolled hypertension or diabetes.
- •Pregnant or breastfeeding.
- •History of craniotomy, burr hole surgery, head trauma, intracranial tumor, vascular malformation, or intracranial surgery.
研究组 & 干预措施
Repetitive Transcranial Alternating Current Stimulation treatment
Experimental
Participants will receive 10 days of repeated transcranial alternating current stimulation in hospital.
干预措施: DC-Stimulator MC (Device)
Sham Repetitive Transcranial Alternating Current Stimulation
Sham Comparator
Participants will receive 10 days of repeated transcranial alternating current stimulation treatment (no active stimulation) in hospital.
干预措施: DC-Stimulator MC (Device)
结局指标
主要结局
Change in visual field mean deviation (MD) from baseline to post-treatment
时间窗: From treatment initiation to 26 days after treatment initiation
Visual field testing will be performed with the Humphrey field analyzer
次要结局
- Visual function analysis from baseline to post-treatment(From treatment initiation to 166 days after treatment initiation)
- Quality of life analysis from baseline to post-treatment(From treatment initiation to 166 days after treatment initiation)
- Optical coherence tomography (OCT) analysis from baseline to post-treatment(From treatment initiation to 166 days after treatment initiation)
- Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment(From treatment initiation to 166 days after treatment initiation)
- Change in visual field mean deviation (MD) from baseline to post-treatment(From treatment initiation to 12 days after treatment initiation)
- Change in visual field mean deviation (MD) from baseline to post-treatment(From treatment initiation to 19 days after treatment initiation)
- Change in targeted mean deviation from baseline to post-treatment(From treatment initiation to 12 days after treatment initiation)
- Change in targeted mean deviation from baseline to post-treatment(From treatment initiation to 19 days after treatment initiation)
- Change in targeted mean deviation from baseline to post-treatment(From treatment initiation to 26 days after treatment initiation)
- Visual function analysis from baseline to post-treatment(From treatment initiation to 5 days after treatment initiation)
- Visual function analysis from baseline to post-treatment(From treatment initiation to 12 days after treatment initiation)
- Visual function analysis from baseline to post-treatment(From treatment initiation to 12 days after treatment initiation])
- Visual function analysis from baseline to post-treatment(From treatment initiation to 26 days after treatment initiation)
- Quality of life analysis from baseline to post-treatment(From treatment initiation to 12 days after treatment initiation)
- Optical coherence tomography (OCT) analysis from baseline to post-treatment(From treatment initiation to 12 days after treatment initiation)
- Optical coherence tomography (OCT) analysis from baseline to post-treatment(From treatment initiation to 26 days after treatment initiation)
- Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment(From treatment initiation to 12 days after treatment initiation)
- Optical coherence tomography angiography(OCT-A) analysis from baseline to post-treatment(From treatment initiation to 26 days after treatment initiation)
- Change in visual field mean deviation (MD) from baseline to post-treatment(From treatment initiation to 166 days after treatment initiation)
- Change in sensitivity at each of the 52 test points in the 24-2 visual field from baseline to post-treatment(From treatment initiation to 26 days after treatment initiation)
- Change in targeted mean deviation from baseline to post-treatment(From treatment initiation to 166 days after treatment initiation)
研究者
研究点 (1)
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